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NCT06388226 · ClinicalTrials.gov registry record · NA

Leg Heat Therapy in Heart Failure With Preserved Ejection Fraction

A NA study of Heart Failure With Preserved Ejection Fraction, sponsored by Indiana University.

Recruiting
Registry status
NA
Development phase
90
Enrollment target
2
Study locations

NCT06388226 is a NA study of Heart Failure With Preserved Ejection Fraction that is actively recruiting participants, run by Indiana University. The registered enrollment target is 90 participants, below the 2,286-participant average among 42 other Heart Failure With Preserved Ejection Fraction trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT06388226, a NA study of Heart Failure With Preserved Ejection Fraction, is actively recruiting participants, sponsored by Indiana University.

RECRUITING
Registry status
NA
Development phase
90 participants
Enrollment target
2
Study locations

Study Summary

The objective of this pilot study is to establish evidence to support the validity of HT in improving skeletal muscle function and physical capacity of patients with HFpEF. Our central hypothesis is that HT treatment will lead to improvements in skeletal muscle and microvascular function compared to a control intervention. As a result, we anticipate that patients treated with HT will demonstrate improved skeletal muscle microvascular blood flow and oxygenation resulting in enhanced exercise tolerance. To explore this hypothesis, we propose the following specific aim: Explore the effects of home-based HT on exercise tolerance in patients with HFpEF.

Conditions Studied

Heart Failure With Preserved Ejection Fraction

Interventions

  • DEVICE Leg heat therapy
  • DEVICE Leg sham therapy

Study Locations (2)

Indiana

  • IU Health Methodist - Indianapolis
  • IU Health University Hospital - Indianapolis

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2024-08-15
Est. Completion 2026-08-31
Phase NA

Sponsor

Indiana University

890 total trials

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What the Registry Record Tells You About NCT06388226

The ClinicalTrials.gov registry entry for NCT06388226 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,286-participant average among 42 other Heart Failure With Preserved Ejection Fraction trials with a reported enrollment target (96% lower). The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Heart Failure With Preserved Ejection Fraction appearing as the primary indexed condition, and to 2 interventions - of which Leg heat therapy is the first listed.

NCT06388226 reports 2 study locations spanning 1 distinct geographic area - top geographies include Indiana.

Frequently Asked Questions

What is clinical trial NCT06388226 about?

NCT06388226 is a clinical study titled "Leg Heat Therapy in Heart Failure With Preserved Ejection Fraction". The objective of this pilot study is to establish evidence to support the validity of HT in improving skeletal muscle function and physical capacity of patients with HFpEF. Our central hypothesis is that HT treatment will lead to improvements in skeletal muscle and microvascular function compared to...

What is the current status of trial NCT06388226?

This trial is currently recruiting. It is a NA study. The enrollment target is 90 participants. The study started on 2024-08-15. Estimated completion is 2026-08-31.

What conditions does trial NCT06388226 study?

This clinical trial studies the following conditions: Heart Failure With Preserved Ejection Fraction.

What interventions are being tested in trial NCT06388226?

The interventions under investigation include: Leg heat therapy (DEVICE), Leg sham therapy (DEVICE).

Who is sponsoring clinical trial NCT06388226?

This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06388226 being conducted?

This trial has 2 study locations across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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