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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The investigators will determine whether daily leg heat therapy for 90 min using water-circulating trousers perfused with water heated to 42ºC improves the time to exhaustion during treadmill exercise testing at 2-month follow-up compared to a sham treatment.

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
Indiana University

890 total trials

What NCT06388226 shows while recruiting

NCT06388226 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 2,286-participant average among 42 other Heart Failure With Preserved Ejection Fraction trials with a reported enrollment target (96% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Heart Failure With Preserved Ejection Fraction

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06388226's enrollment target sits among peer trials

90 17th of 42 higher than 24 of 42 other Heart Failure With Preserved Ejection Fraction trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Heart Failure With Preserved Ejection Fraction trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06388226

Source: ClinicalTrials.gov NCT06388226, the US trial registry maintained by the National Library of Medicine. NCT06388226 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.