Mechanism-based Therapy of Hypotensive Syncope
This research wants to find better ways to help people who faint a lot because of low blood pressure. Fainting spells, known as syncope, can be worrying. This study focuses on a type called 'hypotensive syncope' where your blood pressure drops too low. We're exploring two different approaches to raise blood pressure and reduce these fainting episodes over a year. One approach is for people taking blood pressure lowering medicines – we'll see if carefully reducing or stopping these medicines helps. The second approach is for people whose low blood pressure isn't linked to other medicines; they will receive a medication called fludrocortisone. We'll monitor blood pressure closely to see which method works best to stop fainting spells.
At a glance
What is this study about?
This study is looking for better treatments for severe fainting, known medically as 'syncope.' Specifically, we're focusing on a type of fainting called 'hypotensive syncope,' which happens when your blood pressure drops too low. If you've been experiencing frequent fainting spells that haven't improved with usual advice like staying hydrated or making lifestyle changes, this study might be relevant to you.
The main aim is to see if we can reduce how often people faint by adjusting their blood pressure. We're trying out two different strategies to achieve this. One strategy involves working with people who are currently taking medicines to lower their blood pressure for other conditions. We want to see if carefully reducing or stopping these medicines can help prevent fainting by allowing their blood pressure to be a bit higher. The second strategy is for people whose low blood pressure and fainting aren't related to other medicines. For these individuals, we'll be looking at a medicine called fludrocortisone, which can help increase blood pressure.
Over the course of a year, we'll closely monitor participants' blood pressure using a special cuff worn for 24 hours (a 24-hour blood pressure monitor) and keep track of how many fainting episodes they have. By doing this, we hope to learn which approach is most effective in preventing future fainting spells and improving the quality of life for people living with hypotensive syncope.
Key takeaways
- This study aims to reduce fainting caused by low blood pressure.
- It tests two ways to raise blood pressure: adjusting existing medicines or using fludrocortisone.
- Participation involves careful monitoring of your blood pressure and fainting spells.
- The study lasts for one year with regular check-ups.
- It focuses on severe and frequent fainting not helped by other methods.
Who may be eligible?
To join this study,您 must be at least 18 years old and have a clear medical diagnosis of frequent and severe fainting spells (reflex syncope) that haven't gotten better with standard advice and lifestyle changes. Also, your fainting needs to be linked to low blood pressure. This low blood pressure might be picked up during a 24-hour blood pressure check, or your fainting might happen during special tests that check your body's automatic responses, such as a tilt table test.
There are two main groups within the study. If you're currently taking blood pressure lowering medicines and your doctor thinks it might be possible to adjust them, you could be considered for one part of the study. If you don't take blood pressure lowering medicines but have ongoing low blood pressure, you might be suitable for the other part of the study that involves a different medication.
However, there are reasons you might not be able to join. For example, if you're under 18, have certain heart conditions, or have had a stroke or mini-stroke (TIA) in the past, you wouldn't be able to participate. Also, if your fainting is mild and happens rarely, or if you have other serious medical conditions that could explain your fainting, this study wouldn't be right for you. People who have a specific type of fainting where their heart rate slows down too much during a test, or who have reasons they can't take the study medication (fludrocortisone) would also be excluded.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you at least 18 years old?
- Do you experience frequent, severe fainting spells that haven't improved with advice?
- Has your doctor identified low blood pressure as a cause of your fainting?
- Do you NOT have serious heart disease or a history of stroke?
- Are you able to commit to one year of follow-up and monitoring?
What does participation involve?
If you take part in this study, the doctors and nurses will closely monitor your condition for one year. This will involve regular check-ups and keeping track of your fainting episodes. You will likely have your blood pressure monitored over 24 hours at the beginning and possibly at other times during the study. Depending on which part of the study you are in, you might have changes to your current blood pressure medication (either reducing the dose or stopping it if safe), or you might start a new medication called fludrocortisone. All decisions about medication changes will be carefully managed by the study doctors. You will also have follow-up appointments to discuss how you are feeling and if your fainting has improved. The total duration of your active involvement in the study will be one year, during which your blood pressure and fainting episodes will be regularly assessed.
Potential risks and benefits
Locations (9)
- University of marseille Aix en ProvenceVerified postcodeMarseille, France· Recruiting
- IRCCS Istituto Auxologico ItalianoVerified postcodeMilan, Italy· Recruiting
- IRCCS Istituto Auxologico ItalianoVerified postcodeMilan, Italy· Recruiting
- University of FlorenceVerified postcodeFlorence, Italy· Recruiting
- ospdali del TigullioVerified postcodeLavagna, Italy· Recruiting
- Università della Campania VamvitelliVerified postcodeNaples, Italy· Recruiting
- AMC Universisty of AmsterdamVerified postcodeAmsterdam, Netherlands· Recruiting
- University of Barcelona Vall d'EbronVerified postcodeBarcelona, Spain· Not yet recruiting
- Karolinska InstitutVerified postcodeStockholm, Sweden· Recruiting
Common questions
What is 'hypotensive syncope'?
It's a medical term for fainting (syncope) that happens because your blood pressure drops too low, leading to a temporary lack of blood flow to your brain.
What is '24-hour ambulatory blood pressure monitoring'?
This is when you wear a special blood pressure cuff that automatically takes your blood pressure readings throughout a full day and night, even when you're at home or at work.
What exactly is 'fludrocortisone'?
Fludrocortisone is a medicine that can help your body hold onto salt and water, which in turn can help increase your blood pressure.
Will I have to stop taking my usual medications?
For some participants, the study might involve carefully adjusting (reducing or stopping) blood pressure lowering medicines if it's considered safe and appropriate by the study doctors. This will be discussed with you.
How long will I be involved in the study?
Your active participation in this study will last for one year, during which your condition and any treatments will be closely monitored.
How to find out more
Michele Brignole, MD Cardiologist
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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