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Heart FailureLYFT-HFNCT03141567

LYmphangiogenesis FacTors in Heart Failure States

An observational study of Heart Failure and Heart Failure With Reduced Ejection Fraction, run by Medical University of South Carolina at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Heart failure often causes fluid to accumulate in the body, leading to congestion and swelling. However, some people who have had heart failure for a long time seem to have very little congestion or swelling, even when the heart failure is poorly treated. Read more about this study

Who is it for?
Ages 18 to 99 years
How many people
100 participants
Where
2 sitesUnited States
Study dates
18 May 2017to 24 Jan 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All Inpatient and Outpatient individuals undergoing clincially-indicated right heart catheterization.

Who may be able to join

  • Undergoing clinically indicated right heart catheterization.

Who cannot join

  • Unable to provide consent.
  • Use of medications which may alter lymphangiogenesis factor expression within 365 days
  • Thalidomide, lenalidomide, pomalidomide
  • Bevacizumab
  • Any cytotoxic chemotherapy agents
  • Pregnant
Show all 18Show fewer
  • Any potentially pregnant patient (based on age and gender) undergoes Beta Human chorionic gonadotropin testing as standard of care prior to any right heart catheterization.
  • Active cancer within 365 days
  • Diagnosis of familial or secondary lymphedema
  • Treatment of active bacterial infection within 7 days
  • Active inflammatory rheumatologic disease requiring anti-inflammatory therapy administration within 60 days
  • Conditions
  • Systemic lupus erythematosus
  • Rheumatoid arthritis
  • Scleroderma
  • Inflammatory myositis
  • Vasculitis
  • Behcet's disease

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Ralph H. Johnson VAMC

    Charleston, South Carolina, 29401

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: LYmphangiogenesis FacTors in Heart Failure States (LYFT-HF Study)

Heart failure often causes fluid to accumulate in the body, leading to congestion and swelling. However, some people who have had heart failure for a long time seem to have very little congestion or swelling, even when the heart failure is poorly treated. The investigators think that this is because lymphatic vessels are able to grow and remove fluid to prevent congestion. The investigators do not know how lymphatic vessels grow. This study will investigate the blood levels of various proteins to try to figure out how the lymph vessels of people with long-standing heart failure might grow.

Keywords
Lymphangiogenesis, Heart Failure
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03141567
Study groupRoleWhat they receive
OutpatientIndividuals undergoing clinically indicated Right Heart Catheterization.
InpatientIndividuals undergoing clinically indicated Right Heart Catheterization.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vascular Endothelial Growth Factor (VEGF) Levels

    VEGF levels in systemic venous, pulmonary arterial, and pulmonary venous samples in participants with left heart failure versus those without left heart failure.

    Measured: At time of right heart catheterization

Secondary outcomes (3)

  1. Lymphangiogenesis factors and Pulmonary Capillary Wedge Pressure (PCWP)

    Correlation between above lymphangiogenesis factors and pulmonary capillary wedge pressure, right atrial pressure, and cardiac output gathered from right heart catheterization.

    Measured: At time of right heart catheterization

  2. Lymphangiogenesis and Heart failure severity

    Correlation between lymphangiogenesis factors and heart failure symptom severity as determined by the Kansas City Cardiomyopathy Questionnaire

    Measured: At time of right heart catheterization

  3. Lymphangiogenesis and 6 minute hall walk

    Correlation between lymphangiogenesis factors and 6 minute walk distance.

    Measured: At time of right heart catheterization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2017
  2. Study start18 May 2017
  3. Primary completion3 Feb 2021
  4. Study completion24 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03141567
Sponsor's protocol ID
Pro00062457
Acronym
LYFT-HF
Status last verified
Jul 2023
First submitted
27 Apr 2017
Last updated
14 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure and Heart Failure With Reduced Ejection Fraction, run by Medical University of South Carolina at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vascular Endothelial Growth Factor (VEGF) Levels (time frame: At time of right heart catheterization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03141567.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.

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