CompletedNot Applicable

Acute Intermittent Porphyria Related Abnormalities in Cardiovascular System

Poland180 participantsStarted 2019-04-05

Plain-language summary

This study aims to assess the changes in the cardiovascular system in patients with acute intermittent porphyria (AIP).

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * acute intermittent porphyria (AIP), * age 18-65 years, * at least one hospitalization due to exacerbation of AIP. Exclusion Criteria: * previous myocardial infarction, * heart failure of established (other than porphyria) etiology, * severe heart valve disease, * congenital heart defects, * history of myocarditis, * pacemaker, * hyperthyroidism / hypothyroidism (except for adequate thyroid hormone replacement therapy), * chronic advanced lung diseases, * lack of consent to participate in the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with heart failure and left ventricular dysfunction.

Timeframe: day 1 and up to 2 years in case of the exacerbation of AIP

Number of participants with hypertension.

Timeframe: day 1 and up to 2 years in case of the exacerbation of AIP

Rate of cardiac arrhythmias.

Timeframe: day 1 and up to 2 years in case of the exacerbation of AIP

Trial details

NCT IDNCT05882136

SponsorNational Institute of Cardiology, Warsaw, Poland

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-02-28

View on ClinicalTrials.gov More Porphyrias, Hepatic trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of participants with heart failure and left ventricular dysfunction.

Timeframe: day 1 and up to 2 years in case of the exacerbation of AIP

Number of participants with hypertension.

Timeframe: day 1 and up to 2 years in case of the exacerbation of AIP

Rate of cardiac arrhythmias.

Timeframe: day 1 and up to 2 years in case of the exacerbation of AIP