Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
Become a Member | Sign in
Home>News>This Article

Drug Does Not Improve Set of Cardiovascular Outcomes for Diastolic Heart Failure

Published: Tuesday, April 15, 2014
Last Updated: Tuesday, April 15, 2014
Bookmark and Share
NIH-supported study finds drug does appear to reduce hospitalizations for diastolic heart failure.

A drug that blocks the action of a key hormone did not significantly improve a set of cardiovascular outcomes for patients with diastolic heart failure, a condition in which the heart is stiffer than normal and has problems filling with blood, according to a study supported by the National Institutes of Health.

In terms of the study's primary aim, the results showed no difference in the overall combined endpoint treatments. The study did reduce the rate of heart failure hospitalizations, which was one of the endpoints, in the target population.

The drug, spironolactone, blocks the action of the hormone aldosterone, which is produced in excess in heart failure. The inexpensive generic drug currently is approved to treat patients with systolic heart failure, in which the heart muscle's pumping ability is reduced. There is no specific therapy for diastolic heart failure.

In the current trial, spironolactone did not improve the combined primary endpoints of cardiovascular death, hospitalization for heart failure, or aborted cardiac arrest. Aborted cardiac arrest is a stopped heart that is restarted by CPR or an implanted device.

NIH's National Heart, Lung, and Blood Institute (NHLBI) supported the work, which was published in the April 10 edition of the New England Journal of Medicine. The paper represents the primary results of the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) trial.

Diastolic heart failure, also known as heart failure with preserved systolic function, is a common heart condition accounting for about half of all heart failure cases. The Centers for Disease Control and Prevention estimates that 5.7 million people in the United States have heart failure.

"Heart failure is the most common reason for hospital admissions in the Medicare population, and diastolic heart failure accounts for at least half of these admissions," said Dr. Bertram Pitt of the University of Michigan, Ann Arbor, TOPCAT's study chairman. "Given the high financial and societal costs of these hospitalizations, there is a critical need to find treatments to reduce them. However, no effective therapy for diastolic heart failure has been found to date."

The New England Research Institute and Brigham and Women's Hospital in Boston led the multi-center international research effort involving 3,445 participants, which makes it one of the largest diastolic heart failure trials to date. Researchers enrolled participants in 270 sites spread across the United States, Canada, Argentina, Brazil, the Republic of Georgia, and Russia. Trial participants were randomly placed on spironolactone or a matching placebo and followed for an average of three years.

For the spironolactone group, 319 participants experienced one of the primary outcomes versus 351 in the placebo group, a 9 percent reduction that did not reach statistical significance. For heart failure hospitalizations, 206 people in the spironolactone group were hospitalized versus 245 people in the placebo group, a statistically significant reduction of 16 percent.

"Although TOPCAT did not significantly decrease the combined endpoint or cardiovascular death, spironolactone is the first drug shown to reduce heart failure hospitalizations in this vulnerable population," said Brigham and Women's Hospital's Dr. Marc Pfeffer, the principal investigator.

Spironolactone showed no difference in other serious adverse events, such as dialysis, compared to placebo, although participants taking the drug had higher increased potassium levels than the control group. While use of spironolactone carries the risk of elevated blood potassium levels or reduced kidney function, these risks were low in TOPCAT and can be reduced in clinical practice with careful monitoring.

"This study is an important step in the effort to find effective treatments for diastolic heart failure patients," said Dr. Michael Lauer, director of the NHLBI's Division of Cardiovascular Sciences. "The study examined a broad cross-section of diastolic heart failure patients, and further data analysis may offer clues about sub groups that may particularly benefit from spironolactone treatment."

Initial analysis showed potentially different outcomes based on how a participant qualified for the study. Researchers used two methods to determine which patients with heart failure were eligible to enroll in the study. One method required looked for elevated levels of the hormone BNP, which is associated with more severe heart failure. The other method required looked at a person's history of heart failure hospitalization within the last year.

The study showed that participants enrolled via elevated BNP measurements who received spironolactone fared better in the composite of main outcomes than the BNP group enrolled in the placebo arm. Of the patients enrolled via the BNP criteria, there were 78 patients with events in the spironolactone arm and 116 patients with events in placebo group.

Further analysis showed significant geographic variation in event rates. For patients enrolled in Russia and the Republic of Georgia, 78 patients (10 percent) in the spironolactone arm and 71 patients (8 percent) in the placebo arm reached the composite primary endpoints. For patients in North and South America, 242 patients (27 percent) in the spironolactone arm and 280 patients (4 percent) in the placebo arm reached the composite primary endpoints.

Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,800+ scientific posters on ePosters
  • More than 4,000+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Lucentis Effective for Proliferative Diabetic Retinopathy
NIH-funded clinical trial marks first major advance in therapy in 40 years.
Tuesday, November 24, 2015
Gene Therapy Staves Off Blindness from Retinitis Pigmentosa in Canine Model
NIH-funded study suggests therapeutic window may extend to later-stage disease.
Tuesday, October 20, 2015
Scientists Test New Gene Therapy for Vision Loss from a Mitochondrial Disease
NIH-funded study shows success in targeting mitochondrial DNA in mice.
Tuesday, October 06, 2015
NIH Framework Points The Way Forward For Developing The President’s Precision Medicine Initiative
The NIH Advisory Committee to the Director has presented to NIH Director Francis S. Collins, M.D., Ph.D., a detailed design framework for building a national research participant group, called a cohort, of 1 million or more Americans to expand our knowledge and practice of precision medicine.
Monday, September 21, 2015
Landmark NIH Study Shows Intensive Blood Pressure Management May Save Lives
Lower blood pressure target greatly reduces cardiovascular complications and deaths in older adults.
Saturday, September 12, 2015
NIH Study Finds Calorie Restriction Lowers Some Risk Factors for Age-Related Diseases
Two-year trial did not produce expected metabolic changes, but influenced other life span markers.
Wednesday, September 02, 2015
NIH Study Shows No Benefit of Omega-3 Supplements for Cognitive Decline
Research was published in the Journal of the American Medical Association.
Thursday, August 27, 2015
NIH Launches Human RSV Study
Study aims to understand infection in healthy adults to aid development of RSV medicines, vaccines.
Thursday, August 27, 2015
Dr. Peter Kilmarx Appointed Deputy Director of Fogarty International Center
An expert in infectious disease research and HIV/AIDS prevention.
Wednesday, August 12, 2015
Benefits of Early Antiretroviral Therapy in HIV Infection
Scientists have explored the clinical importance of starting treatment early in individuals suffering with HIV.
Tuesday, August 11, 2015
Young South African Women can Adhere to Daily PrEP Regimen as HIV Prevention
NIH-funded study finds men in Bangkok, Harlem also successful in taking daily dose.
Saturday, July 25, 2015
Study Shows Promise of Precision Medicine for Most Common Type of Lymphoma
The study appeared online July 20, 2015, in Nature Medicine.
Tuesday, July 21, 2015
HIV Control Through Treatment Durably Prevents Heterosexual Transmission of Virus
NIH-funded trial proves suppressive antiretroviral therapy for HIV-infected people effective in protecting uninfected partners.
Tuesday, July 21, 2015
Early Antiretroviral Therapy Prevents Non-AIDS Outcomes in HIV-infected People
NIH-supported findings illustrate manifold benefit of therapy.
Tuesday, July 21, 2015
NIH-funded Vaccine for West Nile Virus Enters Human Clinical Trials
Enrollment is expected to be completed by December 2015.
Tuesday, July 07, 2015
Scientific News
Lucentis Effective for Proliferative Diabetic Retinopathy
NIH-funded clinical trial marks first major advance in therapy in 40 years.
Blocking the Transmission Of Malaria Parasites
Vaccine candidate administered for the first time in humans in a phase I clinical trial led by Oxford University’s Jenner Institute, with partners Imaxio and GSK.
First Therapy Appearing to Reverse Decline in Parkinson’s
An FDA-approved drug for leukemia improved cognition, motor skills and non-motor function in patients with Parkinson’s disease and Lewy body dementia in a small clinical trial, say researchers at Georgetown University Medical Center (GUMC).
Gene Therapy Staves Off Blindness from Retinitis Pigmentosa in Canine Model
NIH-funded study suggests therapeutic window may extend to later-stage disease.
Treatment for Rare Bleeding Disorder is Effective
Researchers in Manchester have demonstrated for the first time the relative safety and effectiveness of treatment, eltrombopag, in children with persistent or chronic immune thrombocytopenia (ITP), as part of an international duo of studies.
HIV Vaccine Human Trials Begin
Baltimore-based Institute has begun enrolling volunteers for initial phase 1 clinical trials.
New Therapy Reduces Symptoms of Inherited Enzyme Deficiency
A phase three clinical trial of a new enzyme replacement medication, sebelipase alfa, showed a reduction in multiple disease-related symptoms in children and adults with lysosomal acid lipase deficiency, an inherited enzyme deficiency that can result in scarring of the liver and high cholesterol.
Fixing Holes in the Heart Without Invasive Surgery
UV-light enabled catheter is a medical device which represents a major shift in how cardiac defects are repaired.
Atriva Therapeutics GmbH Develops Innovative Flu Drug
Highly effective against seasonal and pandemic influenza.
Study Removes Cancer Doubt for Multiple Sclerosis Drug
Researchers from Queen Mary University of London are calling on the medical community to reconsider developing a known drug to treat people with relapsing Multiple sclerosis after new evidence shows it does not increase the risk of cancer as previously thought.
Scroll Up
Scroll Down

Skyscraper Banner
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,800+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,000+ scientific videos