RIDD-HFBH4 Treatment for Diastolic Dysfunction in Heart Failure
This study aims to evaluate the impact of BH4 treatment on diastolic dysfunction in heart failure patients, specifically focusing on changes in oxygen consumption during maximal bike exercise as a measure of cardiovascular health.
Kuvan
Cardiovascular Diseases+3
+ Heart Diseases
+ Heart Failure
Treatment Study
Summary
Study start date: March 1, 2015
Actual date on which the first participant was enrolled.Heart failure is a serious condition affecting millions of people in the United States alone. About half of these individuals have a type of heart failure known as heart failure with preserved ejection fraction (HFpEF), or diastolic heart failure. This condition is characterized by symptoms such as shortness of breath, swelling, fatigue, and reduced exercise tolerance. The causes of diastolic heart failure are not fully understood, making it difficult to treat effectively. Currently, there are no FDA-approved treatments for this condition, and standard heart failure treatments do not work. This study focuses on a potential underlying cause of diastolic heart failure - a decrease in nitric oxide, a substance that helps regulate blood pressure and blood flow. Research suggests that a substance called BH4, which helps produce nitric oxide, might improve diastolic heart failure. However, the effects of BH4 on diastolic heart failure in humans have not been studied yet. In this treatment study, participants will receive BH4 to see if it can improve heart function. The main goal is to measure changes in oxygen consumption during maximum exercise, an indicator of heart and lung health. This will be assessed using a cardiopulmonary exercise test (CPET). The test results will be recorded in milliliters of oxygen per kilogram of body weight per minute (mL/kg/min). An increase in oxygen consumption from the start to the end of the study suggests an improvement in heart and lung health.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.28 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location