Related Experiment Video

Updated: Apr 21, 2026

A Novel Digital Platform for a Monitored Home-based Cardiac Rehabilitation Program
04:24

A Novel Digital Platform for a Monitored Home-based Cardiac Rehabilitation Program

Published on: April 19, 2019

14.2K

Rethinking Phase II Clinical Trial Design in Heart Failure

Kory J Lavine1, Douglas L Mann1

  • 1Center for Cardiovascular Research, Division of Cardiology, Department of Medicine, Washington University School of Medicine, St. Louis, Missouri 63110.

Clinical Investigation
|October 25, 2014
PubMed

Insights

Heart failure therapies face challenges in clinical trials. Current phase II trials struggle to predict success in phase III, necessitating a rethink of heart failure drug development.

Area of Science:

  • Cardiology
  • Clinical Trials
  • Drug Development

Background:

  • Heart failure incidence and economic burden are increasing globally.
  • Despite effective therapies, novel treatments fail in late-stage clinical trials.
  • Previous phase I-II studies have not translated into successful phase III outcomes.

Purpose of the Study:

  • To identify challenges in current phase II heart failure clinical trials.
  • To propose alternative strategies for phase II development of heart failure therapies.

Main Methods:

  • Review of existing literature on phase I-II and phase III clinical trials for heart failure therapies.
  • Analysis of reasons for the failure of novel compounds in phase III trials.

Main Results:

  • Phase II trials often fail to accurately predict the efficacy of novel heart failure therapies in phase III.
  • Inherent limitations in current phase II trial designs contribute to high failure rates.

Conclusions:

  • Rethinking phase II trial design is crucial for successful heart failure drug development.
  • Improved methodologies in phase II trials may enhance the identification of effective heart failure therapies.
Keywords:
Heart failureadaptive study designclinical translationclinical trial designphase II

More Related Videos

Lumped-Parameter and Finite Element Modeling of Heart Failure with Preserved Ejection Fraction09:20

Lumped-Parameter and Finite Element Modeling of Heart Failure with Preserved Ejection Fraction

Published on: February 13, 2021

6.1K
In Silico Clinical Trials for Cardiovascular Disease09:09

In Silico Clinical Trials for Cardiovascular Disease

Published on: May 27, 2022

2.1K

Related Concept Videos

Heart Failure IV: Classification and Diagnostic Evaluation01:30

Heart Failure IV: Classification and Diagnostic Evaluation

Heart failure can be classified in various ways, with the most common classifications based on physical activity limitations, disease progression, severity, and treatment strategies.The Functional Classification of Heart Failure divides patients into four categories based on physical activity limitation due to symptom burden.Class I: Patients in this class have cardiac disease but no physical activity limitations. Ordinary activities like walking, climbing stairs, or routine tasks do not cause...
696
Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
8.5K
Heart Failure II: Pathophysiology01:29

Heart Failure II: Pathophysiology

Systolic Heart Failure and Compensatory MechanismsSystolic heart failure (also termed HFrEF, Heart Failure with Reduced Ejection Fraction) is the most prevalent type of heart filure. It results in a decreased volume of blood being pumped from the ventricle. The aortic arch and carotid sinuses have baroreceptors that detect reduced blood pressure, triggering the sympathetic nervous system (SNS) to release epinephrine and norepinephrine. Initially, this response aims to boost heart rate and...
1.4K
Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
4.6K
Heart Failure III: Clinical Manifestations01:26

Heart Failure III: Clinical Manifestations

Heart failure (HF) manifests primarily as dyspnea, fatigue, and fluid retention, resulting in peripheral and pulmonary edema. Symptoms may vary depending on which ventricle is more affected, left or right.Left-Sided Heart FailureAlso known as left ventricular failure, this condition results from the left ventricle's inability to fill or eject sufficient blood into the systemic circulation. It leads to pulmonary congestion, which occurs when the left ventricle fails to eject blood effectively...
903
Heart Failure VI: Adjunct Therapies01:22

Heart Failure VI: Adjunct Therapies

Additional therapies for treating patients with heart failure (HF) may include procedural interventions, supplemental oxygen, the management of sleep disorders, and nutritional therapy.Procedural InterventionsImplantable Cardioverter-Defibrillator: For patients at risk of life-threatening arrhythmias due to severe left ventricular dysfunction, an Implantable Cardioverter-Defibrillator (ICD) can detect and terminate these arrhythmias, preventing sudden cardiac death and improving survival rates.
624